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Evaluation of Mechanical Stapler for Aortic Anastomoses

Primary Purpose

Aortic Aneurysm, Abdominal, Leriche Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AAA or AF/IB (end-to-end) in patients with Leriche Syndrome
Sponsored by
SVSE 2000 Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient age is between 21 to 85 years old. Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome. Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm. Patient is scheduled for AAA repair Exclusion Criteria: Pregnant women Active malignancy Ruptured aneurysm Thoraco-AAA Patient with at least one of the following unstable risk factors: Renal disease (Cr >2) Ischemic heart disease (unstable Angina) Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam) Severe CHF (EF < 25%) Patient with known allergy to metals or to the contrast media Participation in current or recent (within 60 days prior to surgery) clinical trial

Sites / Locations

  • Augusta Hospital

Outcomes

Primary Outcome Measures

Time to complete each stapled anastomosis.

Secondary Outcome Measures

Post-operative follow up:
no leakage
no dilatation
no fistula or hematoma at the anastomotic sites

Full Information

First Posted
April 27, 2006
Last Updated
October 8, 2006
Sponsor
SVSE 2000 Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00319475
Brief Title
Evaluation of Mechanical Stapler for Aortic Anastomoses
Official Title
Evaluation of Mechanical Stapler for Aortic Anastomoses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
SVSE 2000 Ltd.

4. Oversight

5. Study Description

Brief Summary
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Leriche Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
AAA or AF/IB (end-to-end) in patients with Leriche Syndrome
Primary Outcome Measure Information:
Title
Time to complete each stapled anastomosis.
Secondary Outcome Measure Information:
Title
Post-operative follow up:
Title
no leakage
Title
no dilatation
Title
no fistula or hematoma at the anastomotic sites

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age is between 21 to 85 years old. Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome. Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm. Patient is scheduled for AAA repair Exclusion Criteria: Pregnant women Active malignancy Ruptured aneurysm Thoraco-AAA Patient with at least one of the following unstable risk factors: Renal disease (Cr >2) Ischemic heart disease (unstable Angina) Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam) Severe CHF (EF < 25%) Patient with known allergy to metals or to the contrast media Participation in current or recent (within 60 days prior to surgery) clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Kolvenbach, MD
Organizational Affiliation
Augusta Hospital, Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta Hospital
City
Duesseldorf
ZIP/Postal Code
40472
Country
Germany

12. IPD Sharing Statement

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Evaluation of Mechanical Stapler for Aortic Anastomoses

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